Qa auditor

Macclesfield
Synexa Life Sciences
Auditor
Posted: 21h ago
The role
Role Overview
Key Responsibilities
  • Follow and where applicable implement appropriate laws, regulatory guidelines, SOPs, Study Plans.
  • Participating in the maintenance of the quality system.
  • Forecast, monitor and control the work volume within QAU.
  • Plan and organise all activities within the QAU.
  • Schedule and perform study, facility and process audits in compliance with SOPs.
  • Communicate the audit outcome to relevant personnel and site management and ensure that audit responses are appropriate.
  • To maintain the CAPA system and follow up CAPA actions.
  • Prepare and sign QA statements for inclusion in reports in accordance with SOPs.
  • Submit audit reports for archiving in accordance with the applicable SOP.
  • To approve GMP documentation where applicable.
  • To participate in computerized system validation team where applicable.
  • Review Standard Operating Procedures for consistency and compliance and maintaining QA SOPs.
  • Manage and conduct assessment of key company suppliers as requested by management to ensure compliance with regulatory guidelines.
  • Provide guidance, training and consultation in quality-related issues.
  • Support QA Manager in management and hosting of sponsor and monitoring authority inspections.
  • Observe appropriate regulatory guidelines, SOPs, policies and study documentation.
  • Working in accordance with standard operating procedures (SOPs) by authoring, reviewing, and maintaining SOPs, guidance documents, and policies, as well as providing training and support to staff.

Qualifications & Experience
Required:
  • Minimum 2 years’ experience in GLP, GCP, GMP, or ISO environments.
  • Degree in a relevant natural science.
  • Understanding of national laws and relevant regulations and guidelines and SOPs and site related functions.
  • Proficient in written and spoken English.
  • Strong attention to detail, communication, problem-solving, and organisational skills.
  • Able to work independently and collaborate effectively in a team.
  • Proactive and decisive with a scientific background (desirable).
  • Willing to travel as needed.

PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.
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